The Readout Damian Garde & Meghana Keshavan

Strike two for an erstwhile unicorn

Intarcia, a privately held Boston biotech company, raised more than $1 billion in private funding to get an under-the-skin implant onto the market. Two years and as many FDA rejections later, that plan looks to be in peril.

As STAT’s Kate Sheridan reports, the agency declined to approve ITCA-650, a device that metes out the diabetes treatment exenatide. That’s the second rejection for Intarcia, which resubmitted the product last year after the FDA said no in 2017.

A spokesperson said the company is “extremely disappointed” with the FDA’s decision. Intarcia cut its payroll and reshaped its C-suite and boardroom after the first rejection. The company is now three years removed from its last financing, and it’s unclear what the future holds.

Read more.

PhRMA is closing HQ after coronavirus exposure

PhRMA, the lobbying arm of the drug industry, has shuttered its headquarters for the rest of the week after confirming that someone who had been exposed to the novel coronavirus entered its office last week.

As STAT’s Nicholas Florko reports, PhRMA is now deep-cleaning its Washington headquarters and will keep employees away until March 20.

The group is one of many operating at maximum caution in the wake of a planning meeting at Biogen that resulted in more than 70 presumed or confirmed cases of coronavirus, including one affecting a company executive. Meanwhile, more than 30 scientific and health care-related meetings have been canceled, postponed, or shifted to a webcast as the number of global infections crossed 118,000.

Read more.

The curious incident of the dog in the preclinical study

The vast majority of would-be treatments for humans are first tested on animals, something everyone in the drug industry knows but often shies away from detailing in public. That’s why it was problematic for Paredox Therapeutics when an employee at one of the company’s contractors secretly filmed experiments on dogs and then uploaded the footage to YouTube.

And, as STAT’s Ed Silverman reports, Paredox is suing. The case is against Charles River Laboratories, which runs animal studies for drug makers around the world, and a subsidiary called MPI Research. According to Paredox, an MPI employee who was working undercover for the Humane Society of the United States caused serious damage to the company by posting the video. That forced Paredox to revamp its operations at a “vast” cost, according to the lawsuit.

The suit accuses Charles River of failing to properly screen or supervise the employee in question, and Paredox is seeking monetary damages and a jury trial.

Read more.

How much is a coronavirus drug worth to Alnylam? At least $15 million

Last week, Alnylam and Vir announced they would work together to develop a new coronavirus drug. It seemed rather sensible; Vir has the infectious disease experts, Alnylam has the tech, and the two companies had a pre-existing partnership.

New details revealed in an SEC filing this week provide a little more insight into exactly what that deal will entail. If Vir actually winds up developing a drug, it could owe Alnylam up to $15 million. 

Also interesting: If that drug makes it to market, Vir will pay Alnylam some royalties based on sales — but those royalties will be only“in the low single digits” for “sales to governmental authorities or sales for the purposes of biodefense, management of public health or other public policy reasons.”

More reads

  • Global companies expand the reach of their cancer drugs in China. (STAT Plus)
  • How the Biogen leadership conference in Boston spread the coronavirus. (Boston Globe)
  • Long before coronavirus, Gerald Posner began writing ‘Pharma,’ which warns of ‘The Coming Pandemic.’ (Dallas Morning News)
  • Drug companies, Canadians, and more blast Trump's drug importation plan. (STAT Plus)
  • A coronavirus vaccine will take at least 18 months—if it works at all. (MIT Technology Review)

Thanks for reading! Until tomorrow,

Wednesday, March 11, 2020


Facebook   Twitter   YouTube   Instagram

1 Exchange Pl, Suite 201, Boston, MA 02109
©2020, All Rights Reserved.
I no longer wish to receive STAT emails
Update Email Preferences | Contact Us
5cP.gif?contact_status=<<Contact Status>>